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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K192282
Device Name MedCAD® AccuPlan® System
Applicant
Medcad
501 2nd Ave., Suite A-1000
Dallas,  TX  75226
Applicant Contact Brian Buss
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received08/22/2019
Decision Date 10/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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